K232615
- 510(k) number
- K232615
- Device name
- LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
- Applicant
- Devicor Medical Products, Inc. OH · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2024-01-12
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232615.pdf
Official FDA record: K232615
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.